GlomerulonephritisPhase 4NCT00862693
Calcitriol in the Treatment of Immunoglobulin A Nephropathy
A Phase 4 study testing Calcitriol in people with Glomerulonephritis and Autoimmune Diseases, run by Peking University First Hospital at 1 site in China.
Trial summary
Immunoglobulin A (IgA) nephropathy is the common primary glomerulonephritis in the world. Much literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glomerulonephritis, Autoimmune Diseases
- What is being tested?
- Calcitriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2009to Mar 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- Biopsy-confirmed IgA nephropathy
- Proteinuria > 0.8 g/day in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment for at least 3 months or estimated glomerular filtration rate < 60 ml/min/1.73m2
- Corrected serum calcium level < or = 2.45 mmol/l
- Willingness to give written consent and comply with the study protocol
Who cannot join
- Pregnancy, lactating or childbearing potential without effective method of birth control
- Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
- History of malignancy, including leukemia and lymphoma within the past 2 years
- Systemic infection requiring therapy at study entry
- Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
- History of drug or alcohol abuse within past 2 years
Show all 13Show fewer
- Participation in any previous trial on paricalcitol
- Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 3 months
- Patients receiving treatment of corticosteroid
- On other investigational drugs within last 30 days
- History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
- History of non-compliance
- Known history of sensitivity or allergy to paricalcitol or other vitamin D analogs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renal Division, Peking University First Hospital
Beijing, Beijing Municipality, 100034
Hong Zhang, Prof, +86-10-66551122-2288, hongzh@bjmu.edu.cn
About this study
Immunoglobulin A (IgA) nephropathy is the common primary glomerulonephritis in the world. Much literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy of Calcitriol in the treatment of IgA nephropathy. Forty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to Calcitriol for six months or no treatment. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of Calcitriol in the treatment of IgA nephropathy, which has no specific treatment at present.
- Conditions
- Glomerulonephritis, Autoimmune Diseases
- Being tested
- Calcitriol
- Keywords
- Immunoglobulin A, Antibodies, treatment
- Medical subject headings
- Glomerulonephritis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
0.5ug/Biw
| Study group | Role | What they receive |
|---|---|---|
| 1 calcitriol | Experimental | calcitriol 0.5ug/BIW for 12 months Receives: Drug: Calcitriol |
| 2 | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
decline of urine protein
analysis urine protein after 12 months treatment
Measured: 12 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlomerulonephritisStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862693
- Sponsor's protocol ID
- 20090315
- Status last verified
- Mar 2009
- First submitted
- 16 Mar 2009
- Last updated
- 17 Feb 2011
- Results posted
- No
Publications
Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
PubMed 38299639
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcitriol in the Treatment of Immunoglobulin A Nephropathy
- ClinicalTrials.gov ID
- NCT00862693
- Acronym / sponsor ID
- 20090315
- Conditions
- Glomerulonephritis, Autoimmune Diseases
- Keywords
- Immunoglobulin A, Antibodies, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 17 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immunoglobulin A (IgA) nephropathy is the common primary glomerulonephritis in the world. Much literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy of Calcitriol in the treatment of IgA nephropathy. Forty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to Calcitriol for six months or no treatment. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of Calcitriol in the treatment of IgA nephropathy, which has no specific treatment at present.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 calcitriol | Experimental | Drug: Calcitriolcalcitriol 0.5ug/BIW for 12 months |
| 2 | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65 years
- Biopsy-confirmed IgA nephropathy
- Proteinuria > 0.8 g/day in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment for at least 3 months or estimated glomerular filtration rate < 60 ml/min/1.73m2
- Corrected serum calcium level < or = 2.45 mmol/l
- Willingness to give written consent and comply with the study protocol
Key exclusion criteria (13 listed)
- Pregnancy, lactating or childbearing potential without effective method of birth control
- Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
- History of malignancy, including leukemia and lymphoma within the past 2 years
- Systemic infection requiring therapy at study entry
- Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcitriol0.5ug/Biw | Drug | 1 calcitriol |
Primary outcome
decline of urine protein
Time frame: 12 months treatment
analysis urine protein after 12 months treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
- Derived from this study: PubMed 38299639Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcitriol in people with Glomerulonephritis and Autoimmune Diseases, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Zhang, Prof (+86-10-66551122-2288, hongzh@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decline of urine protein (time frame: 12 months treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00862693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2011.